Gastroesophageal VaricesNCT04984863
MCCE in Assessing Efficacy of Gastro-oesophageal Varices
A study of Gastroesophageal Varices, run by Ruijin Hospital at 1 site in China.
Trial summary
This study proposed for the first time the use of MCE to evaluate the efficacy of the treatment of gastroesophageal varices, and compared the examination results with the gold standard to explore whether MCE could replace the electronic gastroscopy as the preferred non-invasive evaluation method for the treatment of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Varices
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old
- Confirmed cirrhosis by clinical or pathological biopsy
- Previous endoscopic treatment of esophageal and gastric varices, including but not limited to sclerotherapy, injection of tissue adhesives, skin entrapment, etc
- Electronic gastroscopy is to be performed
- Voluntary informed consent
Who cannot join
- Absolute contraindications:
- Patients without surgical conditions or refusing any abdominal surgery (once the capsule is stranded, it cannot be removed by surgery)
- There is a pacemaker in the body, except that the pacemaker is a new MRI compatible product
- Electronic devices such as cochlear implants, magnetic metal drug infusion pumps, nerve stimulators and magnetic metal foreign bodies are implanted in the body;
- .Women during pregnancy
- Relative contraindication:
- Gastrointestinal obstruction, stenosis, and fistula are known or suspected
- Dysphagia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200433
Yao Zhang, M.D., +86-18019076695, zyrjxh97@sjtu.edu.cn
Duowu Zou, M.D., +86-13901617608, zdw12125@rjh.com.cn
About this study
Official title: Clinical Usefulness of Magnetically Controlled Capsule Endoscopy in Assessing Efficacy of Gastro-oesophageal Varices in Patients With Liver Cirrhosis Treated Under Gastroscopy: a Prospective, Multicenter Trial
This study proposed for the first time the use of MCE to evaluate the efficacy of the treatment of gastroesophageal varices, and compared the examination results with the gold standard to explore whether MCE could replace the electronic gastroscopy as the preferred non-invasive evaluation method for the treatment of gastroesophageal varices.
Read the detailed description
Gastro-esophageal varices is one of the complications of portal hypertension in cirrhosis. For patients with moderate to severe varicose veins, international guidelines recommend active treatment, including endoscopic therapy such as endoscopic band ligation (EBL) and interventional radiotherapy such as balloon-occluded retrograde transvenous obliteration (B-RTO)Electronic gastroscopy is the gold standard for the diagnosis of varicose veins at higher blood risk (varicose veins requiring retreatment). However, it is relatively invasive and uncomfortable in the examination process, so that patients with gain-and-compensation cirrhosis are often unwilling to accept it, which is not conducive to the standardized follow-up after the treatment of gastro-esophageal varices.Magnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa. Patients only need to swallow a capsule endoscope to make repeated observation for many times, and the examination process is painless. It is an ideal method for diagnosing varicose veins with high blood risk (varicose veins that need treatment). Therefore, this study proposed for the first time the use of MCE to evaluate the efficacy of the treatment of gastroesophageal varices, and compared the examination results with the gold standard to explore whether MCE could replace the electronic gastroscopy as the preferred non-invasive evaluation method for the treatment of gastroesophageal varices.
- Conditions
- Gastroesophageal Varices
- Being tested
- Magnetically controlled capsule endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetically controlled capsule endoscopyDevice
Magnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa.
| Study group | Role | What they receive |
|---|---|---|
| magnetically controlled capsule endoscopy | Experimental | magnetically controlled capsule endoscopy to evaluate the efficacy of the treatment of gastroesophageal varices Receives: Device: Magnetically controlled capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the clinical usefulness of MCE in assessing the efficacy of gastro-oesophageal varices treated under gastroscopy.
Comparing the value of MCE and gastroscopy in the grading of esophagogastric varices
Measured: 15-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Jan 2020
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal VaricesStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duowu Zou, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984863
- Sponsor's protocol ID
- RuijinH20190228
- Status last verified
- Jan 2021
- First submitted
- 31 Jan 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018 Aug;69(2):406-460. doi: 10.1016/j.jhep.2018.03.024. Epub 2018 Apr 10. No abstract available.
PubMed 29653741Cremers I, Ribeiro S. Management of variceal and nonvariceal upper gastrointestinal bleeding in patients with cirrhosis. Ther Adv Gastroenterol. 2014 Sep;7(5):206-16. doi: 10.1177/1756283X14538688.
PubMed 25177367de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
PubMed 26047908Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
PubMed 27786365Groszmann RJ, Garcia-Tsao G, Bosch J, Grace ND, Burroughs AK, Planas R, Escorsell A, Garcia-Pagan JC, Patch D, Matloff DS, Gao H, Makuch R; Portal Hypertension Collaborative Group. Beta-blockers to prevent gastroesophageal varices in patients with cirrhosis. N Engl J Med. 2005 Nov 24;353(21):2254-61. doi: 10.1056/NEJMoa044456.
PubMed 16306522Merli M, Nicolini G, Angeloni S, Rinaldi V, De Santis A, Merkel C, Attili AF, Riggio O. Incidence and natural history of small esophageal varices in cirrhotic patients. J Hepatol. 2003 Mar;38(3):266-72. doi: 10.1016/s0168-8278(02)00420-8.
PubMed 12586291
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usefulness of Magnetically Controlled Capsule Endoscopy in Assessing Efficacy of Gastro-oesophageal Varices in Patients With Liver Cirrhosis Treated Under Gastroscopy: a Prospective, Multicenter Trial
- ClinicalTrials.gov ID
- NCT04984863
- Acronym / sponsor ID
- RuijinH20190228
- Conditions
- Gastroesophageal Varices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposed for the first time the use of MCE to evaluate the efficacy of the treatment of gastroesophageal varices, and compared the examination results with the gold standard to explore whether MCE could replace the electronic gastroscopy as the preferred non-invasive evaluation method for the treatment of gastroesophageal varices.
Detailed description
Gastro-esophageal varices is one of the complications of portal hypertension in cirrhosis. For patients with moderate to severe varicose veins, international guidelines recommend active treatment, including endoscopic therapy such as endoscopic band ligation (EBL) and interventional radiotherapy such as balloon-occluded retrograde transvenous obliteration (B-RTO)Electronic gastroscopy is the gold standard for the diagnosis of varicose veins at higher blood risk (varicose veins requiring retreatment). However, it is relatively invasive and uncomfortable in the examination process, so that patients with gain-and-compensation cirrhosis are often unwilling to accept it, which is not conducive to the standardized follow-up after the treatment of gastro-esophageal varices.Magnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa. Patients only need to swallow a capsule endoscope to make repeated observation for many times, and the examination process is painless. It is an ideal method for diagnosing varicose veins with high blood risk (varicose veins that need treatment). Therefore, this study proposed for the first time the use of MCE to evaluate the efficacy of the treatment of gastroesophageal varices, and compared the examination results with the gold standard to explore whether MCE could replace the electronic gastroscopy as the preferred non-invasive evaluation method for the treatment of gastroesophageal varices.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| magnetically controlled capsule endoscopy | Experimental | Device: Magnetically controlled capsule endoscopymagnetically controlled capsule endoscopy to evaluate the efficacy of the treatment of gastroesophageal varices |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-75 years old
- Confirmed cirrhosis by clinical or pathological biopsy
- Previous endoscopic treatment of esophageal and gastric varices, including but not limited to sclerotherapy, injection of tissue adhesives, skin entrapment, etc
- Electronic gastroscopy is to be performed
- Voluntary informed consent
Key exclusion criteria (8 listed)
- Patients without surgical conditions or refusing any abdominal surgery (once the capsule is stranded, it cannot be removed by surgery)
- There is a pacemaker in the body, except that the pacemaker is a new MRI compatible product
- Electronic devices such as cochlear implants, magnetic metal drug infusion pumps, nerve stimulators and magnetic metal foreign bodies are implanted in the body;
- .Women during pregnancy
- Gastrointestinal obstruction, stenosis, and fistula are known or suspected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetically controlled capsule endoscopyMagnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa. | Device | magnetically controlled capsule endoscopy |
Primary outcome
Evaluating the clinical usefulness of MCE in assessing the efficacy of gastro-oesophageal varices treated under gastroscopy.
Time frame: 15-30 minutes
Comparing the value of MCE and gastroscopy in the grading of esophagogastric varices
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Results publication: PubMed 29653741European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018 Aug;69(2):406-460. doi: 10.1016/j.jhep.2018.03.024. Epub 2018 Apr 10. No abstract available.
- Results publication: PubMed 25177367Cremers I, Ribeiro S. Management of variceal and nonvariceal upper gastrointestinal bleeding in patients with cirrhosis. Ther Adv Gastroenterol. 2014 Sep;7(5):206-16. doi: 10.1177/1756283X14538688.
- Results publication: PubMed 26047908de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
- Results publication: PubMed 27786365Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
- Results publication: PubMed 16306522Groszmann RJ, Garcia-Tsao G, Bosch J, Grace ND, Burroughs AK, Planas R, Escorsell A, Garcia-Pagan JC, Patch D, Matloff DS, Gao H, Makuch R; Portal Hypertension Collaborative Group. Beta-blockers to prevent gastroesophageal varices in patients with cirrhosis. N Engl J Med. 2005 Nov 24;353(21):2254-61. doi: 10.1056/NEJMoa044456.
- Results publication: PubMed 12586291Merli M, Nicolini G, Angeloni S, Rinaldi V, De Santis A, Merkel C, Attili AF, Riggio O. Incidence and natural history of small esophageal varices in cirrhotic patients. J Hepatol. 2003 Mar;38(3):266-72. doi: 10.1016/s0168-8278(02)00420-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duowu Zou principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Gastroesophageal Varices, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duowu Zou, M.D. (+86-13901617608, zdw12125@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the clinical usefulness of MCE in assessing the efficacy of gastro-oesophageal varices treated under gastroscopy. (time frame: 15-30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04984863, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.